MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2014-12-17 for UNIVERSAL TITANIUM PROSTHESIS 1150001 manufactured by Medtronic Xomed Inc..
[19358472]
It was reported that a? Universal titanium prosthesis, cam head, with flex h/a titanium shoe broke while being implanted in the patients ear. A small metal piece was lost in the middle ear and the doctor was unable to visualize it and said,? I cannot find it and if i go digging around i can cause more damage.? So the decision was made not to retrieve it.?
Patient Sequence No: 1, Text Type: D, B5
[19539356]
This device is used for therapeutic purposes. Note: we were notified of this event when we received a copy of the facility? S voluntary medwatch form on december 3, 2014. (b)(4): product evaluation: analysis could not be performed; device remains in patient? S ear and will not be returned for evaluation. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[101038995]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00330 |
| MDR Report Key | 4338383 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-09-29 |
| Date Mfgr Received | 2014-12-03 |
| Device Manufacturer Date | 2013-08-13 |
| Date Added to Maude | 2014-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL TITANIUM PROSTHESIS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2014-12-17 |
| Model Number | 1150001 |
| Catalog Number | 1150001 |
| Lot Number | 0207296386 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-17 |